Office-based Vision Therapy for Improving Reading and Attention in Children With Convergence Insufficiency

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Convergence Insufficiency

In brief

CITT-ART is a multicenter study (8 locations around the United States) of 324 children ages 9 to \<14 years with symptomatic convergence insufficiency (CI). The purpose of this study is to see if office-based therapy for convergence insufficiency (CI) improves reading ability and attention. CI is an eye-teaming problem where the eyes would like to drift outward when reading or doing close work. When eyes drift out, double vision can happen. To prevent double vision one must use extra effort to keep the eyes from going out. This extra effort can cause symptoms that can interfere with reading and working comfortably at near. These symptoms often include eyestrain, blurred vision, headaches, double vision, and loss of place when reading or performing tasks at near. In a prior study we found that therapy improves these symptoms. In this study we are looking at whether the therapy improves reading and attention

Key facts

Study ID

NCT02207517

Run by

Salus University

People needed

311

Starts

2014-05-01

Expected to finish

2020-11-01

Last updated by the study team

2020-03-17

Who can join

Age: 9 and older, up to 13. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 9 to less than 14 years
• Grades 3 through 8
• CI Symptom Survey (CISS) score greater or equal to 16
• Exophoria at near at least 4 prism diopters greater than at far
• Receded near point of convergence (NPC) of 6 cm or greater break
• Insufficient positive fusional vergence (PFV) at near (i.e., failing Sheard's or PFV less than or equal to 15 BO break)
• Best-corrected distance visual acuity of 20/25 or better in each eye
• Random dot stereopsis appreciation of 500 seconds of arc or better
• Wearing appropriate refractive correction (spectacles or contact lenses) for at least 2 weeks prior to final determination of eligibility for any of the following uncorrected refractive errors (based on cycloplegic refraction within prior 12 months)
• Myopia greater than -0.75D spherical equivalent (SE) in either eye
• Hyperopia greater than +2.00D SE in either eye
• SE anisometropia greater than 0.75D
• Astigmatism greater than 1.00D in either eye
• Correction for patients meeting above refractive error criteria must meet the following guidelines:
• SE anisometropia must be within 0. 75D of the full anisometropic correction
• Astigmatism must be within 0.75D of full correction; axis must be within 6◦ if astigmatism greater than or equal to 1.00D
• For hyperopia, the sphere can be reduced by up to 1.50 D provided reduction is symmetrical
• For myopia, the SE must be within 0.75D of the full myopic correction
• No use of BI prism or plus add at near for 2 weeks prior to study and for duration of study
• English is primary language spoken at home or child proficient in English as determined by the school
• Parent does not expect child to start any new ADHD medicine or change the dose of any currently taken ADHD medicine while child is being treated in the study
• Parental permission to contact the child's teacher(s) for study purposes
• Parent and child understand protocol and are willing to accept randomization

You may not qualify if…

• Constant strabismus at distance or near
• Esophoria of greater than or equal to 2∆ at distance
• Vertical heterophoria greater than or equal to 2∆ at distance or near
• greater than or equal to 2 line interocular difference in best-corrected distance visual acuity
• Monocular near point of accommodation greater than 20 cm (accommodative amplitude less than 5D) in right eye
• Manifest or latent nystagmus
• Word Reading subtest score less than 80 on the Wide Range Achievement Test (WRAT-4)
• Kaufman Brief Intelligence Test (KBIT-2) Matrices subtest score less than 70
• History of prior strabismus, intraocular, or refractive surgery
• CI previously treated with any form of office-based vergence/accommodative therapy or home-based vergence therapy (e.g., computerized vergence therapy)
• CI associated with head trauma or known disease of the brain
• Diseases known to affect accommodation, vergence, or ocular motility
• Inability to comprehend and/or perform any study-related test or therapy procedure
• Speech-language disorder (e.g., stuttering) that would interfere with interpretation of digital recordings of reading tests
• Significant hearing loss
• Household member enrolled in present CITT-ART, treated currently, or treated within the past 6 months with any form of office-based vergence/accommodative therapy or home-based vergence therapy (e.g., computerized vergence therapy)
• Parent or other household member is an eye care professional, ophthalmic technician, ophthalmology or optometry resident, or optometry student

Where it is running

• University of Alabama, Birmingham College of Optometry — Birmingham, Alabama, United States
• Southern California College of Optometry Marshall B. Ketchum University — Fullerton, California, United States
• NOVA Southeastern University College of Optometry — Fort Lauderdale, Florida, United States
• Bascom Palmer Eye Institute — Miami, Florida, United States
• State University of Optometry College of Optometry — New York, New York, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Ohio State University College of Optometry — Columbus, Ohio, United States
• Pennsylvania College of Optometry at Salus University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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